This invention relates generally to an apparatus and method for developing an anatomic space for laparoscopic procedures, and more specifically, to an apparatus and method that provides for laparoscopic visualization both during tunneling dissection to the desired anatomic space as well as during subsequent tissue dissection during balloon inflation once the desired potential space has been identified.
In the past, in developing spaces and potential spaces within a body, blunt dissectors or soft-tipped dissectors have been utilized to create a dissected space which is parallel to the plane in which the dissectors are introduced into the body tissue. This often may be in an undesired plane, which can lead to bleeding which may obscure the field and make it difficult to identify the body structures. In utilizing such apparatus and methods, attempts have been made to develop anatomic spaces in the anterior, posterior or lateral to the peritoneum. The same is true for pleural spaces and other anatomic spaces. Procedures that have been performed in such spaces include varicocele dissection, lymph node dissection, sympathectomy and hernia repair. In the past, the inguinal hernia repair has principally been accomplished by the use of an open procedure which involves an incision in the groin to expose the defect in the inguinal floor, removal of the hernial sac and subsequent suturing the ligaments and fascias together to reinforce the weakness in the abdominal wall. Recently, laparoscopic hernia repairs have been attempted by inserting laparoscopic instruments into the abdominal cavity through the peritoneum and then placing a mesh patch over the hernia defect. Hernia repair using this procedure has a number of disadvantages, principally because the mesh used for the hernia repair is in direct contact with the structures in the abdominal cavity, as for example the intestines, there is a tendency for adhesions to form between these structures. Such adhesions are known to be responsible for certain occasionally serious complications. Such a procedure is also undesirable because typically the patch is stapled to the peritoneum, which is a very thin unstable layer covering the inner abdomen. Thus, the stapled patch can tear away from the peritoneum or shift its position. Other laparoscopic approaches involve cutting away the peritoneum and stapling it closed. This is time consuming, however, and involves the risk that important anatomic structures may be inadvertently cut. In addition, such a procedure is undesirable because it requires the use of a general anesthesia. There is therefore a need for a new and improved apparatus and method for developing an anatomic space and particularly for accomplishing hernia repair by laparoscopy.
This invention relates generally to an apparatus and method for developing an anatomic space for laparoscopic procedures, and more specifically, to an apparatus and method that provides for laparoscopic visualization both during tunneling dissection to the desired anatomic space as well as during subsequent tissue dissection during balloon inflation once the desired potential space has been identified.
In the past, in developing spaces and potential spaces within a body, blunt dissectors or soft-tipped dissectors have been utilized to create a dissected space which is parallel to the plane in which the dissectors are introduced into the body tissue. This often may be in an undesired plane, which can lead to bleeding which may obscure the field and make it difficult to identify the body structures. In utilizing such apparatus and methods, attempts have been made to develop anatomic spaces in the anterior, posterior or lateral to the peritoneum. The same is true for pleural spaces and other anatomic spaces. Procedures that have been performed in such spaces include varicocele dissection, lymph node dissection, sympathectomy and hernia repair.
Previously, the inguinal hernia repair has principally been accomplished by the use of an open procedure which involves an incision in the groin to expose the defect in the inguinal floor, removal of the hernial sac and subsequent suturing the ligaments and fascias together to reinforce the weakness in the abdominal wall. Recently, laparoscopic hernia repairs have been attempted by inserting laparoscopic instruments into the abdominal cavity through the peritoneum and then placing a mesh patch over the hernia defect. Hernia repair using this procedure has a number of disadvantages, principally because the mesh used for the hernia repair is in direct contact with the structures in the abdominal cavity, as for example the intestines, there is a tendency for adhesions to form between these structures. Such adhesions are known to be responsible for certain occasionally serious complications. Such a procedure is also undesirable because typically the patch is stapled to the peritoneum, which is a very thin unstable layer covering the inner abdomen. Thus, the stapled patch can tear away from the peritoneum or shift its position. Other laparoscopic approaches involve cutting away the peritoneum and stapling it closed. This is time consuming, however, and involves the risk that important anatomic structures may be inadvertently cut. In addition, such a procedure is undesirable because it requires the use of a general anesthesia. There is therefore a need for a new and improved apparatus and method for developing an anatomic space and particularly for accomplishing hernia repair by laparoscopy.
In general, the apparatus of the present invention is used for insertion into a body to create an anatomic space. In one embodiment of the invention, the apparatus is comprised of a tubular introducer device having a bore extending therethrough. A tunneling shaft is slidably mounted in the bore and has proximal and distal extremities including a bullet-shaped tip. A rounded tunneling member is mounted on the distal extremity of the tunneling shaft. An inflatable balloon is provided. Means is provided on the balloon for removably securing the balloon to the tunneling shaft. Means is also provided for forming a balloon inflation lumen for inflating the balloon. The balloon is wrapped on the tunneling shaft. A cover substantially encloses the balloon and retains and compresses the balloon in a tightly wrapped envelope. The cover may be removably coupled to the tunneling shaft. The cover is provided with a weakened region extending longitudinally thereof, permitting the cover to be removed whereby the balloon can be unwrapped and inflated so that it lies generally in a plane.
The method of use of the laparoscopic surgical apparatus according to the present invention may now be summarily described as follows. The surgeon first identifies the tissue layers to be dissected. The surgeon makes a small incision in the skin of the patient at or near the location of the tissue layers. The surgeon then introduces the laparoscopic apparatus, with the rounded tunneling member entering first. The apparatus is advanced by bluntly tunneling between the tissue layers until the balloon reaches the desired location between the tissue layers. The cover is then removed. The cover can be removed by pulling it proximally such that it separates along the longitudinal weakened region. Alternatively, the cover can be removed by inflating the balloon, causing the balloon to expand and thereby separating the cover along the weakened region. The balloon is inflated by introducing an inflation fluid through the inflation lumen. Inflating the balloon causes the balloon to unwrap. Further inflation causes the balloon to expand thereby pushing apart and dissecting the tissue layers.
Once the desired amount of tissue dissection has taken place, the balloon is deflated, preferably by evacuating the balloon using an operating room vacuum system. The balloon may be removed by pulling it proximally causing it to separate from the tunneling shaft. The remainder of the apparatus is held in place to preserve access to the region of newly dissected tissue.
After the balloon is removed, the introducer device may be advanced over the tunneling shaft into or near the region dissected by inflation of the balloon. The tunneling shaft performs the function of maintaining ready access to the dissected region. The tunneling shaft and rounded tunneling member may be removed by pulling them distally through the bore of the introducer device.
The dissected region can then be retracted by any suitable method, such as by insufflation. The laparoscopic dissection device may be equipped with the fittings, valves and fluid pathways needed to introduce insufflation pressure to the dissected region. Surgical instruments may be inserted through the introducer device for performing a surgical procedure in the dissected region. Further, one of more additional cannulas can be introduced in various positions about the dissected region through which surgical instruments can be introduced for performing a surgical procedure in the dissected region of tissue.
In another embodiment of the present invention, an apparatus and method is provided for creating a dissected region between tissue layers wherein laparoscopic visualization is enabled during tunneling dissection to the desired location and/or during tissue dissection by balloon inflation. The laparoscopic device comprises an elongate tubular tunneling member formed of a suitable transparent material having a handle attached to the proximal end, The tunneling member has a bore sized to accommodate a laparoscope. A balloon, also made of a transparent material, is disposed on the tunneling member. The balloon may be rolled, folded, and/or wrapped around the tunneling member to minimize its size so that it may be conveniently inserted through a small incision. A balloon cover may be provided as an integral part of the balloon or as a separate removable sleeve. The balloon cover may have a weakened region extending longitudinally and which may be split to remove the cover from the balloon.
The operation of the visualization laparoscopic device is as follows. First of all, a laparoscope is inserted into the bore of the tunneling member. The device is then inserted through an incision as described above in connection with the previous embodiment. The progress of the tunneling can be observed via the laparoscope through the transparent tunneling member and balloon. After the desired location is reached, the balloon cover is removed.
The balloon is inflated causing the balloon to expand and dissect the tissue layers. During inflation, the surrounding tissues can be viewed via the laparoscope. This may allow visualization of anatomic landmarks which can help determine when the desired amount of dissection has taken place. After the balloon dissection has been completed, the balloon is then deflated.
The balloon, tunneling member and laparoscope may then be removed from the incision. A suitable cannula is inserted into the incision. Thereafter, retraction can be accomplished and a laparoscopic surgical procedure can be performed in the dissected region as previously described.
In another aspect of the present invention, it is often advantageous to preserve the access and the path back to the dissected region after the tunneling member, laparoscope and/or balloon have been removed. Various devices and methods are disclosed herein. In one embodiment, a skin seal having an enlarged bore is slidably received on the tunneling member. Prior to removing the balloon, tunneling member and laparoscope from the incision, the skin seal is slid down the tunneling member into the incision such that a seal is formed between the perimeter of the incision and the skin seal. The skin seal can be installed at any appropriate point during the procedure, for example, prior to inflation of the balloon or after balloon dissection has been completed. After the skin seal is in place, and after balloon dissection has been accomplished, the balloon, tunneling member and laparoscope are removed by holding the skin seal stationary in place and by pulling the deflated balloon, tunneling member and laparoscope through the bore of the skin seal. The skin seal helps to preserve the location of the recently dissected region and saves a path back to the dissected region. A cannula may then be inserted through the bore of the skin seal and fixed to the skin seal to hold the cannula in place.
In another embodiment of the present invention including a device and method for preserving the dissected region, the laparoscopic device may be provided with a channel guide. In this embodiment, the balloon is attached to the channel guide instead of the tubular tunneling member. The balloon has an elongate neck which is attached to the channel guide at or near the proximal end of the channel guide. The distal portion of the balloon is still preferably wrapped around the tunneling member. The channel guide is preferably a U-shaped, elongate device having a ring attached to the proximal end. The ring and U-shaped guide each have a radius configured to slidably receive the tunneling member.
The method of using the laparoscopic device with the channel guide is substantially the same as the methods described above with respect to previous embodiments except for the following differences. During the step of tunneling the device to the desired location, the device is inserted so that the channel guide is advanced through the incision with at least the ring remaining outside the incision. Once the balloon dissection has been completed and the balloon has been deflated, the channel guide is held in position and the tunneling member and laparoscope are removed through the channel guide and ring, leaving the channel guide and balloon within the incision to provide a path back to the dissected region.
Next, a cannula, and optionally a skin seal, are slid over the channel guide, through the incision and advanced into the previously dissected region. The channel guide and balloon may then be removed from the patient through the cannula and skin seal.
In an alternative method of using the channel guide, the cannula and skin seal may be installed on the laparoscope (with the tunneling member removed and discarded). While holding the channel guide in place, the laparoscope is inserted back into the incision using the channel guide to guide the scope shaft to the dissected region. While holding the laparoscope, together with the cannula and skin seal, the channel guide and attached balloon are removed through the incision. At this point, the cannula and skin seal can be advanced over the laparoscope and into the incision. The skin seal is secured in place as described above.
In yet another embodiment of the present invention wherein the device and method preserves the dissected region, the laparoscopic device includes an endoscope guide. The endoscope guide may be used in addition to the channel guide described above, or it may be used without the channel guide. If the channel guide is not provided, then the proximal end of the balloon neck may be sealed to another device such as the ring previously described. The endoscope guide comprises a tube with a handle provided at the proximal end of the tube. The tube may be provided with a slit extending longitudinally along the entire length of the underside of the endoscope guide. The slit allows the endoscope guide to separate from the balloon, channel guide and tunneling member as the balloon is inflated.
In use, the addition of the endoscope guide slightly alters the procedure. After balloon deflation, the tunneling member and laparoscope are completely removed leaving the endoscope guide, deflated balloon, and channel guide (if used) in place within the incision. While holding the endoscope guide in place, the balloon and channel guide are removed through the incision. After removing the tunneling member, a cannula and skin seal are loaded onto the laparoscope. The distal end of the laparoscope is inserted through the endoscope guide which provides a path back to the dissected region. The endoscope guide may be removed and the cannula and skin seal advanced over the laparoscope and into the incision and dissected region.
In still another embodiment of the present invention for providing a path back to the previously dissected region, the laparoscopic device may be provided with an innovative space saver guide comprising an elongate rod and a cup shaped tip attached to the distal end of the rod. The space saver guide is particularly useful in conjunction with the xe2x80x9cone-piecexe2x80x9d balloon dissectors disclosed herein. The term xe2x80x9cone-piecexe2x80x9d is used to identify the balloon dissectors which have the tubular tunneling member inserted into the interior of the balloon and the proximal end of the balloon is permanently attached to the tunneling member. A handle may be attached to the proximal end of the tubular tunneling member and preferably has a bore through it aligned with the bore in the tubular member. The bore in the handle accommodates a laparoscope to be inserted therethrough and into the tubular tunneling member. With this construction, the balloon cannot be removed after inflation independent of the tunneling member. Hence, to remove the balloon the tunneling member must also be removed and nothing is left in the dissected region to preserve the location. Notwithstanding, it is to be understood that the space saver guide is very versatile and may easily be adapted for use with any of the balloon dissectors disclosed herein with only minor modifications to the balloon dissector.
For the sake of brevity, the space saver guide will be described in connection with a one-piece balloon dissector. The cup shaped tip is configured to cover the distal tip of the tubular tunneling member and the wrapped balloon. An integral or separate balloon cover may be provided to secure the balloon about the tunneling member. An elongate semi-flexible rod is attached to the cup shaped tip and extends proximally along the balloon dissector.
A cannula and optional obturator are provided and are configured to cooperate with the space saver guide. Assuming the obturator is used, the obturator is enclosed within the cannula with the distal end of the obturator extending beyond the distal end of the cannula. The obturator and cannula are provided with guide lumens configured to receive the rod of the space saver guide.
Use of the space saver guide is as follows. The balloon dissector with the space saver guide installed (i.e. the cup shaped placed on the tip of the balloon dissector and the rod extending proximally along the dissector) is inserted through an incision and is tunneled to the desired location for balloon dissection. The cup shaped tip acts as a blunt tipped obturator for blunt tunneling. At this stage of the procedure, the cannula and obturator remain outside the incision. Once the balloon is in the desired location, the cup is disengaged from the tip. If a balloon cover is utilized, the cover is removed and the balloon is inflated. After the desired balloon dissection has been accomplished, the balloon is deflated.
To remove the balloon, the guide is held in place and the balloon and tunneling member are pulled out through the incision. The cup shaped tip and attached rod preserve the dissected space and provide a convenient path back to the dissected region. The cannula and obturator are advanced into the incision by placing the guide lumens over the proximal end of the rod. The rod guides the cannula and obturator back to the dissected region.
If the cannula includes a skin seal, the skin seal is set in the incision. The rod and cup of the guide are retracted to the tip of the obturator and then the obturator and guide are completely removed from the body through the bore of the cannula. Finally, a surgical procedure may be performed in the dissected region as described above, for example, by inserting surgical instruments through the bore of the cannula.
In general, it is an object of the present invention to provide an apparatus and method for developing an anatomic space.
Another object of the invention is to provide an apparatus and method in which such an anatomic space is developed by applying perpendicular forces to create the anatomic space at the weakest plane to create a more natural, less traumatic and bloodless region in which to work.
Another object of the invention is to provide an apparatus and method to obtain surgical exposure in the preperitoneal space.
Another object of the invention is to provide an apparatus and method to create preperitoneal working space utilizing a balloon dissector.
Another object of the present invention is to provide an apparatus and method of the above character for developing an anatomic space for laparoscopic hernia repair through the anatomic space.
Another object of the invention is to provide an apparatus and method for decreasing the time and risk associated with creating a preperitoneal working space.
Another object of the invention is to provide an apparatus and method of the above character for a minimally invasive procedure.
Another object of the invention is to provide an apparatus and method of the above character which can be accomplished without the use of general anesthesia.
Another object of the invention is to provide an apparatus and method of the above character which can be accomplished with a spinal or epidural anesthesia.
Another object of the invention is to provide an apparatus and method of the above character which provides substantially reduced medical costs and a greatly reduced patient recovery time.
Another object of the invention is to provide an apparatus of the above character which is relatively simple and compact.
Another object of the invention is to provide an apparatus and method of the above character which can be readily utilized by surgeons.
Another object of the invention is to provide a patch for use with the apparatus which is firmly secured during the hernia repair.
Another object of the invention is to provide a balloon which has a modified asymmetric manta ray configuration to aid in providing the desired configuration for the extraperitoneal working space for hernia repair.
Another object of the invention is to provide a balloon dissection apparatus which has a balloon cover detachably secured to an obturator so that the balloon dissection device is relatively rigid to permit the balloon dissection apparatus to be grasped by the handle to operate the same during dissection.
Another object of the invention is to provide a balloon dissection apparatus of the above character in which a precise release mechanism is provided for releasing the balloon cover from the obturator so that the surgeon can be assured that the balloon cover has been released before it is removed to release the balloon.
Another object of the invention is to provide a balloon dissection apparatus of the above character in which the guide rod or obturator remains in place to maintain ready access to the extraperitoneal working space.
Another object of the invention is to provide a balloon dissection apparatus of the above character in which certain of the parts which are to be moved relative to other parts are color coded to aid the surgeon in use of the apparatus.
Another object of the apparatus is to provide a tubular member which is provided with a tip having an inclined surface.
Another object of the invention is to provide a balloon dissection apparatus which is provided with a blunt tip which has a diameter which is less than the diameter of the cannula tube.
Another object of the invention is to provide a balloon dissection apparatus of the above character in which at least a part of the same can be sterilized and reused.
Another object of the invention is to provide an apparatus and method of the above character which has been simplified.
Another object of the invention is to provide an apparatus and method of the above character which decreases the number of steps required to complete a dissection process.
Another object of the invention is to provide an apparatus and method which permits a visualization of the insertion of the balloon into the posterior rectus space at the time of insertion.
Another object of the invention is to provide an apparatus of the above character which makes it possible to utilize conventional cannulae.
Another object of the invention is to provide an apparatus of the above character which makes it possible to utilize a laparoscope during the surgical procedure to permit viewing of the dissection as it is occurring.
Another object of the invention is to provide an apparatus of the above character in which laparoscopic observation can be accomplished through the balloon if desired as dissection is taking place.
Another object of the invention is to provide an apparatus of the above character in which a separate removable sheath is not required for encasing the balloon prior to inflation.
Another object of the invention is to provide an inflatable balloon which can be utilized to dissect around obstructions.
Another object of the invention is to provide a balloon utilized for dissection which is provided in laterally inwardly extending folds to aid in dissecting as the balloon is inflated.
Another object of the invention is to provide a laparoscopic apparatus including a tunneling member, channel guide and balloon assembly into which a conventional laparoscope may be inserted for visualization of anatomic structures as the tunneling member and laparoscope are advanced through an incision to the desired location within the body where dissection of tissue layers is desired.
Another object of the invention is to provide a tunneling member and balloon assembly of the above character wherein the tunneling member has an open distal end that permits a laparoscope to be advanced outside the tunneling member into the interior of the balloon during balloon inflation to permit observation of tissue dissection through a single balloon layer.
Another object of the invention is to provide a tunneling member and balloon assembly of the above character which includes a U shaped channel guide that remains within the incision site after the tunneling member and laparoscope are withdrawn to provide reliable access back to the previously created space.
Another object of the invention is to provide an apparatus of the above character in which a separate removable sheath is not required to cover the balloon prior to inflation.
Another object of the invention is to provide an apparatus of the above character which includes an optional endoscope guide which may be inserted into the incision during tunneling dissection to preserve access to the created space for subsequent laparoscopic procedures.
Additional objects and features of the invention will appear from the following description in which the preferred embodiments are set forth in detail in conjunction with the accompanying drawings.